Questions regarding registration, updating contact information (including address), or to cancel a registration. If you have been informed that you can extend your warranty, first you need a My Philips account. You can create one here. Monitor Philips' actions related to the repair or replacement of impacted devices until Philips has met all requirements related to the conduct of their Class I recall and the Medical Device Quality System regulation. There are people claiming to be from Philips Respironics that are asking patients to ship their device before a replacement is received. Release certain chemicals, such as VOCs into the device's air tubes and be inhaled by the user. Carefully evaluate the totality of information available to the FDA in determining appropriate next steps. These issues may result in serious injury that can cause permanent impairment or even be life-threatening. The devices included are CPAP machines due to issues related to the polyester-based polyurethane sound abatement foam used in its continuous and non-continuous ventilators. We are aware that Philips Respironics said to stop using your CPAP or BiPAP device. Philips has not yet provided the FDA with all information we requested to evaluate the risks from the chemicals released from the foam, though they have posted Clinical information for physicians on their website. The FDA has reached this determination based on an overall benefit-risk assessment. A locked padlock
Although MDRs are a valuable source of information, this passive surveillance system has limitations. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. There are currently no items in your shopping cart. You can also visit philips.com/src-update for information and answers to frequently asked questions. Do not stop or change ventilator use until you have talked to your health care provider. hb```:mAd`0pl`:aZ A0v0D4H4v%e9b> c, SC2S%MX
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The FDAs in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports. Sign up for exclusive news and promotions Easily find information and accessories for all your Philips products. Philips Respironics issued a statement on September 1, 2021 informing United States-based customers of its new repair and replacement program for first-generation DreamStation devices in relation to the June 14, 2021 recall notification.The vast majority of the registered affected devicesmore than 80%are from the first-generation DreamStation product family, and more than half of the . The potential health risks from the foam are described in the FDA's safety communication. Home | Philips Recall (expertinquiry.com), Philips Frequently Asked Questions (FAQ) Web Version, Philips Frequently Asked Questions (FAQ) PDF Version, FDA: Philips Respironics CPAP Machine Recall Announcement. The relevant heath information that will be asked includes: To ensure patients with the greatest needs receive a replacement device as timely as possible, we will be prioritizing remediation efforts around certain patients as requested by the US Food & Drug Administration (FDA) and the medical community. Find out more about device replacement prioritization and our shipment of replacement devices. You are about to visit the Philips USA website. Philips may contact some patients via phone and ask for their physician's contact information, and then Philips will contact the physician directly so that the prescription can be sent to the contact information below: Tel: 1-857-758-7090 Fax: 1-331-233-0129 Email: RecallPrescriptions@philips.com PAP Recall Guidance The full report is available here. Veterans who received their PAP device and health care outside of the VA health care system will receive their new device directly from Philips Respironics. When the PE-PUR foam breaks down, it may: The potential risks of particulate exposure if inhaling or swallowing pieces of PE-PUR foam include: The potential risks of inhaling chemicals released into the device's air tubes from the PE-PUR foam include: During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. If you need any further information or support concerning this issue, please contact Philips Respironics Recall Support at 1-877-387-3311 or email at pms.fac@philips.com. Work with other manufacturers and government partners to try to help make available more BiPAP and CPAP machines. It may also lead to more foam or chemicals entering the air tubing of the device. Devices authorized for repair and replacement include DreamStation CPAP and BiLevel devices, DreamStation ASV devices, and DreamStation ST/AVAPS devices. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. For further information about your current status, please log in to the Patient Portal or call 877-907-7508. Patients who have additional concerns should talk to their health care provider about the plan for their care and treatment. There are no updates to this guidance. For patients using life-sustaining ventilation, continue prescribed therapy. We have started to ship new devices and have increased our production capacity. As the situation is constantly evolving, we will continue to make sure that both you and your care team have the most up-to-date information until you receive your replacement device. For Veterans who received their PAP device from the VA, your replacement device may come from either VA or Philips Respironics. Before sharing sensitive information, make sure you're on a federal government site. Our Prescription Team is required to review all prescriptions. You can create one here. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers, and patients. Didn't include your email during registration? For a list of the affected devices and more information regarding the recall from Philips Respironics you can go to: https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateChapters:00:00 Intro00:44 Find Your Serial Number01:49 Online Form06:05 Demand for CPAP MachinesShop Online: Our Store: https://sleeplay.comCPAP Machines: https://sleeplay.com/collections/cpap-machinesCPAP Masks: https://sleeplay.com/collections/cpap-masksCPAP Cleaning: https://sleeplay.com/collections/cpap-cleaningCPAP Supplies: https://sleeplay.com/collections/cpap-suppliesOxygen Therapy: https://sleeplay.com/collections/oxygen-therapyGo Social:Facebook: https://facebook.com/sleeplaygroundInstagram: https://instagram.com/sleeplaygroundTwitter: https://twitter.com/sleeplayground TikTok: https://tiktok.com/@sleeplaygroundBecome an Affiliate:https://sleeplay.refersion.com/affiliate/registrationFree Consultation:https://calendly.com/sleeplay/respiratory-therapist-consultation Philips Respironics has issued a . All rights reserved. Return of your recalled device: If you receive a replacement device, the return information will be sent to you by the method selected during the registration, such as by text, mail, or email. The site is secure. You can still register your device on DreamMapper to view your therapy data. We recommend you upload your proof of purchase, so you always have it in case you need it. You can log in or create one here. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. For patients usingBiLevelPAP and CPAP devices, consult with your physician on a suitable treatment plan. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replace program discontinue use of their product. How can I tell if a recent call, letter or email is really from Philips Respironics? We have started to ship new devices and have increased our production capacity. Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall. Continuous Positive Airway Pressure (CPAP) devices, Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and, Or by calling 877-907-7508 (Spanish translation available but the patient will still need to go online to register their device). Why do I need to upload a proof of purchase? Place your affected device in the cardboard package in which you received your replacement device, Please do not send your accessories back to us. Philips Respironics portal to register your recalled device: REGISTER MY DEVICE . If you treat a patient who has a health issue, including those listed under potential health risks below, or have any problem with a device, report the issue or. Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. First, determine if you are using one of the affected devices. In addition to shipping devices directly from Philips Respironics, they are providing devices to VA to increase shipping volume. Once you've registered your device, please remember to save your confirmation number which will be emailed to you. Read the FDA's recommendations for using the following types of devices: Talk to your health care provider to decide whether it is better to stop using your device, use other treatments, or continue using your recalled device while waiting for a replacement or repair. On June 14, 2021, Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and Ventilator Devices due to two issues related to deterioration of the sound abatement foam used in these devices. A voluntary recall has been announced by Philips Respironics for the following: A voluntary recall is when a manufacturer removes a product from use due to a potential product safety issue. Use another similar device that is not a part of this recall. We are currently reaching out to some patients via email, mail and phone and will ask for additional information to complete certain remediations. 2. While we work to provide patients with a replacement device as quickly as possible, we want you to feel informed about each step of the remediation process, and confident in your new device. Those being treated for sleep apnea by the WTC Health Program may be using one of the impacted machines. Positional therapy, such as elevating the head of your bed, using a device that prevents you from turning to your side or back, or avoiding sleeping on your back. 3. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replace program. If you do not find your device on the list of recalled models or during registration: You may want to contact the medical equipment supplier (commonly known as a Durable Medical Equipment (DME) supplier) who gave you your device. The U.S. Food and Drug Administration (FDA) is updating the June 2021 safety communication about the Philips Respironics (Philips) recalled ventilators, bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines. This guidance has been updated from our previous recommendation to stop therapy before consulting withyour physician. You may have to contact your care provider to program the device to your prescribed settings. If you use a Philips Respironics CPAP or BiPAP device that is included in the recall, continue using your device as prescribed until a new device is available. Be aware that during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs). We continue to work with Philips to ensure that the company takes appropriate steps to correct the products. Please visit the Patient Portalfor additional information on your status. benefits outweigh the risks identified in the recall notification. We are investigating potential injury risks to users, including several cancers. Keep your registration confirmation number. More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov. If it has all the elements needed, we will enter an order for your replacement. If you have a health issue, including those listed under potential health risks below, or any problem with your device, talk to your health care provider and. The .gov means its official.Federal government websites often end in .gov or .mil. Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. VA has distributed approximately 300,000 Philips CPAP or BiLevel PAP devices for Veteran . Philips submitted 30 MDRs between 2011-April 2021 that they identified as associated with the PE-PUR foam degradation (breakdown). Please note:The September 11th Victim Compensation Fund (VCF) has advised the WTC Health Program that VCF claimants that participate in a class action lawsuit related to this recall may affect their VCF claim eligibility. Philips Respironics continues to monitor recall awareness for affected patients [1]. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Once your order is placed the order number will be listed in the Patient Portal. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. It is possible to see different phone numbers from Philips Respironics call centers or emails from different email addresses. With your MyPhilips account you can: Access all your product information in one place (orders, subscriptions, etc.) Can we help? The company formally submitted their Report of Correction and Removal (a report under 21 CFR part 806, or 806 report) in June 2021. No. News and Updates> Important update to Philips US recall notification. Philips Respironics Recall Information On June 14, 2021, Philips Respironics announced a voluntary recall of all CPAP, BiPAP, and Ventilator devices manufactured prior to April 21, 2021. More information on. To register a new purchase, please have the product on hand and log into your My Philips account. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Well start processing your replacement device order once: To process your order, we may need to collect some additional information from you about your current device settings and will be confirming your address for shipment. For further information about your current status, please log into the portal or call 877-907-7508. To register your product, youll need to log in to your My Philips account. 1. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. All rights reserved. All rights reserved. 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